Gene patents and democracy

by jeeg 1. April 2011 21:22

On 4 April, the US Court of Appeals for the Federal Circuit in Washington, DC will review a case that calls into question patents on human genes. Much of the debate has focused on how the case might reshape the future of biotechnology research and genomic medicine. But what is at least as important, if not more so, are the case’s positive implications for democratic engagement in the patent system, which could ultimately enhance the social benefits of innovation.

The case stems from a legal challenge, mounted in the fall of 2009, by a coalition of scientists, physicians, and patient advocacy groups represented by the American Civil Liberties Union. They filed suit against biotechnology company Myriad Genetics and the US Patent and Trademark Office, challenging the patentability of genes linked to breast and ovarian cancer. These groups alleged that Myriad’s patents are invalid under Supreme Court precedent and that they limit patient access to testing, increase health care costs, jeopardize testing quality, interfere with research collaboration, and privatize what once were public goods.

In a surprising move for a patent-related case, the NY federal district court judge granted these parties “legal standing.” Only parties who have been directly affected by a particular issue can file a lawsuit, and in patent cases, these parties had previously been those who hold, and those who infringe on, patent rights. But in the Myriad case, the judge accepted that the patients, scientists, and physicians had suffered enough harm to sue.

In March 2010, the judge ruled in favor of the coalition. Overturning decades of patent office practice, he stated that human genes were unpatentable because they are “products of nature”. Myriad has now appealed the decision.

Between the “legal standing” ruling and the widespread public discussion—from 60 Minutes to The Huffington Post — that this case has inspired, we could be on the brink of a new era of greater public engagement in the patent system. Unfortunately, the small group of stakeholders who now shape US patent policy has historically tried to prevent this type of participation. They argue that social, ethical, health, and environmental concerns are irrelevant to patent issues. The system, they say, is objective, technical, and designed simply to reward inventors with intellectual property rights. Furthermore, they say, consideration of these issues could stifle innovation.

I disagree. A more democratically engaged patent system can lead to better social outcomes. Allowing citizens to participate in determining the boundaries of our patent system encourages awareness of and perhaps even direct involvement in the innovation process. The involvement of patient advocates in discussions about biomedical research policy has led not only to increased funding, but also to citizen involvement in research itself. This ranges from active involvement in collecting blood and saliva samples for genetics research to local community-based efforts to map whether and how patterns of cancer incidence are linked to specific environments.

Also, “lay” members of the public can provide a fresh perspective, identifying issues that patent insiders simply cannot see because they are accustomed to “business as usual”. For example, we have traditionally focused on the patent system’s responsibility to the public interest in terms of fostering increased innovation and producing a larger, healthier economy. But patient advocates and international development organizations, including Doctors without Borders, have demonstrated that while patents on medicines might spur industrial growth and development, they also create monopolies that make many medicines prohibitively expensive. In sum, they observed a much more nuanced and complex relationship between the patent system and society than patent system insiders saw. As a result, they were able to suggest a variety of innovative measures that the patent system might consider to better balance economic benefit and public health — from alternative approaches to patent examination to new regimes for intellectual property.

Regardless of the appeals court’s decision in the Myriad case, the widespread citizen involvement that has surrounded it and that promises to intensify in its wake has opened the door to an uncertain and exciting phase in the politics of patent policy. We must encourage insiders to hold the doors firmly open, recognizing the value that average citizens can bring to the patent system and ultimately, to the innovation process.

Shobita Parthasarathy, Nature

 

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